Radio Frequency Identification (RFID) is an emerging technology with numerous applications, e.g. as smart labels or tags. RFID devices respectively RFID tags vary greatly in their cost and capabilities. At the low end, there are low-cost tags that are passive, getting their power from the reader, with limited computational, storage, and communication capabilities. Major applications of such tags are as replacements for barcodes being used for Electronic Product Codes (EPC) tags and as a track-and-trace tool to prevent product counterfeiting e.g. in the pharmaceuticals industry. Further, RFID tags are used in production and/or logistics in order to individually trace the treatment for each article to be produced.
The counterfeit of medical drugs represents nowadays a concrete threat, not only to the revenues of pharmaceutical companies, but also to the safety of people who consume the drugs. In light of this threat, drug manufacturers as well as government bodies have started to take action, aiming at providing greater levels of security to the whole medical drug supply chain. In the United States, the responsible Food and Drug Administration (FDA) has recognized the need for technological solutions in addition to solutions such as tamper-evident packaging and authentication technologies such as color shifting inks, holograms, fingerprints and chemical markers embedded in a drug or its label. In this spirit, the FDA has recommended the use of RFID technology as a further tool against drug counterfeiting.
The deployment of RFID technology with mass serialization involves assigning a unique identification code ID to each pallet, case and package of drugs. This ID can be used to record data about all sales and transactions involving the product thus providing an “e-pedigree” from drug manufacturing to dispensing (drug track and trace), and to allow the drug purchaser to determine a drug's authenticity. The full data associated with the RFID tag can further be used in a number of other applications such as inventory control, drug diversion prevention and rapid drug recall. The implementation would start at the case and pallet level and progressively include all products at the case, pallet and package level, to eventually allow identification of the drug at the product level throughout the distribution system.
Track and trace technologies help secure the integrity of the drug supply chain by providing an accurate drug pedigree. Current paper based procedures are prone to errors and tampering, and are not practical to be applied at the item respectively product level. Therefore, electronic track and trace (via RFID technology) is not only the most promising approach to reliable product tracking and tracing but also has cost-reducing benefits in other areas such as inventory management. Drug authentication is crucial not only to determine a drug's authenticity upon purchase, but also in providing a drug's e-pedigree. Therefore, electronic authentication via RFID technology, together with other existing authentication technologies, can provide a more reliable basis for drug verification and track and trace.
U.S. Pat. No. 6,842,106 B2 discloses a method of securing communications in an RFID system including a reader and an RF tag having a memory configured to store information. The method comprises sending, from the reader, a message to the tag. In response to the message, the tag generates a challenge value and sends the challenge value to the reader. The reader performs a mathematical operation on the challenge value based upon a key value to generate a challenge reply and sends the challenge reply to the tag. The tag independently computes a challenge response based on the key value and a mathematical operation. The tag compares the challenge response computed by the tag with the challenge reply sent by the reader. The tag authenticates the reader if the challenge response matches the challenge reply.
GB 2 413 195 A discloses a memory tag and a reader with a password protection of the tag memory. The memory tag in the form of an RFID includes a memory storing data, an operating program and a current password. The memory tag is operable, in response to a read signal from a tag reader requesting data, to run the operating program to check the read signal for inclusion of a token dependent upon the current password. If the token is identified within the reader signal, the memory tag is operable to read the requested data and transmit it to the reader. The token may be the password itself, or a derivative of the password. The tag password may be set at the time of manufacture, or updated after each communication from the tag to the reader. Alternatively the tag receives a new password from the reader after transmitting the requested data. The current token and new passwords may be sent in encrypted form.
In the publication “Securing the pharmaceutic supply chain by Robin Koh, Edmund W. Schuster, Indy Chackrabarti, Attilio Bellman; Auto ID Center Massachusetts Institute of Technology; June 2003; http://www.mitdatacenter.org/MIT-AUTOID-WH021.pdf” there is proposed a scheme for drug authentication and drug e-pedigree, as the drug passes from organization to organization in the supply chain. The information structure for pedigrees uses a supply chain wide central repository, which increases accessibility to pedigree information to all parties in the supply chain. From each organization in the supply chain, information needed for a drug pedigree such as an Electronic Product Code (EPC) is written into this repository. The information structure for drug verification centers on files located at the manufacturer, a subset of which contains only valid EPCs, which can be extracted from the manufacturer servers and posted for secure Internet access. Other supply chain organizations can then scan the EPC from a drug and compare it to valid EPCs posted by the manufacturer. However, it is possible that a valid EPC can be adulterated as it goes out of the manufacturer's control.
In the publication “Securing the Pharmaceutical Supply Chain with RFID and Public-key infrastructure Technologies by Joseph Pearson; Texas Instruments Radio Frequency Identification Systems; RFIDPH01-June 2005; http://www.ti.com/rfid/docs/manuals/whtPapers/wp-Securing_Pharma_Supply_Chain_w_RFID_and_PKI_final.pdf” there is proposed a further scheme for drug authentication and drug pedigree, as the drug passes through the supply chain. RFID tag authentication is performed by authenticated readers, which verify the digital signature of the drug manufacturer on the unique tag identifier and the drug manufacturer identifier. This signature is made upon drug manufacturing. Track and trace functionality is achieved also with the help of the readers. They record and also write to the tag “event markers”, which are essentially the date and time of supply chain events. The readers also communicate relevant event information, digitally signed by them, to the local computer system. This system, on its turn, makes the information available to an external network. This provides an inseparable link and look-up index between the tag, the supply chain event and external distributed network data, as the event marker is made available through the network at each event in the supply chain.
The schemes above prevent that genuine tags be re-written with bogus identifiers or that fake tags be programmed with bogus identifiers. However, they do not prevent that valid identifiers be read from genuine tags and copied into fake tags which can be then attached to counterfeit products. In case two or more identical identifiers are found at different points in the supply chain, the counterfeiting attack can be detected. However, the fake product may enter the supply chain before the genuine product, so the fake drug may be taken as the genuine one. Moreover, in case the genuine products are simply removed from the supply chain and replaced by the fake ones, the counterfeit attack can be successful. After the replacement, drug verification would furnish correct identifiers and track and trace would continue as usual, as if the values read from the fake tags came from genuine tags.
In the light of the above identified problems there may be a need for providing a solution in order to prevent or at least to make it more difficult to read genuine RFID devices and have their data copied into fake RFID devices, which can then be attached to fake products and replace genuine products in the supply chain in particular for pharmaceutic products.